Pharmaceutical Administration Law of the People's Republic of China
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1985.07.01
STANDING COMMITTEE OF THE NATIONAL PEOPLE'S CONGRESS
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA

(Adopted　at　the　Seventh　Meeting　of　the Standing Committee of the
Sixth　National　 People's　Congress　and promulgated by Order No. 18 of
the　President　of　 the　 People's　 Republic of China on September 20,
1984, and effective as of July 1, 1985)

CHAPTER III ADMINISTRATION OF PHARMACEUTICAL TRADING ENTERPRISES
　@@　 Article　 10.　 The　 establishment　 of a pharmaceutical trading
enterprise　must　 be　 sanctioned　 by　the local competent authorities
for　the　production and　 trading　 of　 pharmaceuticals　and　approved
by　 the　 administrative　department　 of　 health　 at　or　above　the
county　level,　which　will　issue a Pharmaceutical　Trading　Enterprise
Licence.　The　administrative　authorities　for　industry　and　commerce
shall　 not　 issue　business　licences　to　any enterprises without the
Pharmaceutical Trading Enterprise Licence.
　The　 Pharmaceutical　 Trading　 Enterprise　 Licence　 shall　have　a
period　of　validity,　upon　expiration　of which a new licence shall be
issued　after　an　examination　 for　 its　renewal.　Detailed　measures
for　the　renewal　of　such　licences　 shall　 be　 stipulated　by　the
administrative department of health under the State Council.
　 @@　　Article　　11.　　To　 establish　 a　 pharmaceutical　 trading
enterprise, the following requirements must be met:
　(1)　 It　 shall　be staffed with pharmaceutical technicians qualified
for the handling of the pharmaceuticals.
　If　 an　 enterprise　trading　in　Chinese traditional medicines or an
enterprise　 concurrently　　trading　 in　 medicines　 does　 not　have
pharmaceutical　 technicians,　it　 shall　 be　 staffed　 instead　with
pharmaceutical　workers　who　are familiar with　the　properties　of the
medicines　it　trades　in　and　are　registered　with the administrative
department of health at or above the county level.
　(2)　It　shall　have　business premises, equipment, storage facilities
and　a sanitary environment suitable for the pharmaceuticals in which it
trades.
　 @@　 Article　 12.　 The　 quality　 of　 pharmaceuticals　 must　 be
inspected　 on　purchasing.　 Pharmaceuticals　 that　 do　 not meet the
required standards must not be purchased.
　@@　Article　13.　It　is　imperative,　in the sale of pharmaceuticals,
to　be　accurate　 and　 free　 of　mistakes,　and　to　provide　correct
directions　for　use,　dosage　 and　 precautions.　Prescriptions　being
dispensed　 must　be　checked. Pharmaceuticals　listed　in prescriptions
must　not　be　presumptuously　changed or　 substituted.　 Prescriptions
containing　 incompatible　 substances　or excessive　dosages　shall　be
rejected　by　the　dispensary. If necessary, such prescriptions　can　be
dispensed　after　they have been corrected or re-signed by　the　doctors
who　 wrote　 them　 out.　 When　famous　traditional　Chinese medicinal
materials are offered for sale, their origin must be indicated.
　@@　 Article　 14.　 Rules　 for　 storage of pharmaceuticals shall be
formulated　and　implemented　by　pharmaceutical　warehouses, which must
adopt　 necessary　 measures　　to　　facilitate　　cold　 storage　 and
protection　against　moisture, insects and rodents.
　An　 inspection　 system　 shall　be　carried　out for pharmaceuticals
entering or leaving warehouses.
　@@　 Article　 15.　 Unless　 otherwise　 stipulated　 by　the　state,
traditional　Chinese　medicinal　materials　may　be marketed at urban or
rural fairs.
　Pharmaceuticals　 other　 than traditional Chinese medicinal materials
may　not　be　 sold　 at　urban or rural fairs, except by those who have
Pharmaceuticals Trading Enterprise Licences.

CHAPTER IV ADMINISTRATION OF PHARMACEUTICALS AT MEDICAL UNITS
　@@　 Article　 16.　Medical　units must be staffed with pharmaceutical
technical　personnel　 commensurate　 with　 their　 medical　functions.
Non-pharmaceutical　technical　 personnel　may　not　engage　directly in
pharmaceutical technical work.
　@@　 Article　 17.　To　make　medicinal　preparations,　a medical unit
must　be　examined,　 approved　and　issued　a　Dispensing Permit by the
administrative　department　 of　 health　 of　 the province, autonomous
region,　or　municipality directly under the Central Government in which
the unit is located.
　The　 Dispensing　 Permit　 shall　have　a　period　of　validity, upon
expiration　 of　which　 a　 new　 permit　 shall　be　issued　after　an
examination　for　its　renewal. Detailed　measures　for　the　renewal of
such　permits　shall　be　stipulated by the administrative department of
health under the State Council.
　@@　 Article　　18.　 Medical　 units　making　medicinal　preparations
must　 be　equipped　 with　 facilities,　 inspection　 instruments　and
sanitary conditions capable of ensuring the quality of the preparations.
　@@　 Article　 19.　The　quality of the medicinal preparations made by
medical　units　 must　 be　 inspected　 in　 accordance　with　relevant
regulations　 and　clinical　needs.　Those up to standard can be used as
the doctor prescribes.
　Medicinal　preparations　made　by medical units may not be sold on the
market.
　@@　 Article　 20.　Medical　units　must implement a system of quality
inspection when purchasing pharmaceuticals.

CHAPTER V PHARMACEUTICAL ADMINISTRATION
　@@　 Article　21.　The　state　encourages　research on and development
of new medicines.
　When　 working　on　a　new　medicine,　it　is　necessary to submit, as
required,　　the　　methods　　 of　　 production,　　quality　 indices,
pharmacological　and　toxicological　testing　　results,　　and　　other
related　　materials　　and　 sales　 to　the administrative　department
of　 health　 under　 the　 State　 Council　or　to　the　administrative
department　 of　 health　 of　the relevant province, autonomous region,
or　 municipality　 directly　 under　 the　Central Government. Clinical
tests or clinical verifications can be carried out only after approval.
　A　　new　 medicine　 which　 has　completed　its　clinical　tests　or
clinical　verification　　and　 been　 approved　after　appraisal　shall
be　 issued　 a　certificate　 by　 the　 administrative　department　of
health under the State Council.
　@@　 Article　 22.　 A　 new　medicine can be put into production only
after　the　administrative　department of health under the State Council
has approved it and　issued　a registered document of approval. However,
this　does not apply to　the production of traditional Chinese medicines
prepared in ready-to-use forms.
　A　medicine　standardized by the state or by a province, an autonomous
region,　or　 a　 municipality　 directly　under　the Central Government
shall　 be　 put　into　production　 only　 after　 the　 administrative
department　 of　health　of the relevant　province,　autonomous　region,
or　municipality　directly　under the Central　Government　has　made　an
examination　 of　 the　 medicine,　given　it　approval　 and　issued　a
registered　document　of　approval, seeking beforehand the　opinions　of
the　 authorities　 at　 the　 same　level　in　charge of the production
and　 trading　 of　 medicines.　However,　this　does　not　apply to the
production　of　traditional　Chinese　medicines prepared in ready-to-use
forms.
　@@　 Article　 23.　 Pharmaceuticals　 must　meet　the　pharmaceutical
standards　of　the　 state　 or　 those　 of　 the　 relevant　province,
autonomous　　region,　　or　municipality　directly　under　the　Central
Government.
　The　 Pharmacopoeia　 of　the　People's　Republic　of　China　and　the
pharmaceutical　standards　promulgated　by the administrative department
of　health　under　the　State　Council shall be the State pharmaceutical
standards.
　The　 Pharmacopoeia　Committee　of　the　administrative　department of
health　under　the State Council shall be responsible for organizing the
formulation and revision of the state pharmaceutical standards.
　@@　Article　24.　The　administrative　department　of health under the
State　Council　and　administrative　departments of health of provinces,
autonomous　regions,　and　municipalities　directly　under　the　Central
Government　may establish　pharmaceuticals　examination　and　evaluation
committees　to　carry out　examination　and　evaluation of new medicines
and re-evaluate medicines already put into production.
　@@　Article　25.　The　administrative　department　of health under the
State　Council　 shall　organize　investigations on medicines which have
been　 approved　 for　 production.　 It　shall　revoke　the　registered
documents　of　approval if it discovers　that　the　medicines'　curative
effects　are uncertain or poor, or that　they　produce　serious　adverse
reactions　or　for　other reasons are harmful to people's health.
　Production　 and　sale　of the medicines whose registered documents of
approval　have　 been　 revoked　 shall　not　be　allowed　to　continue;
those　which　have　already　　been　 produced　shall　be　destroyed　or
disposed　 of　 under　 the　supervision　of　the　local　administrative
department of health.
　@@　 Article　 26.　Import　of　medicines　whose　curative effects are
uncertain　or　poor,　or　which　produce adverse reactions or have other
harmful effects on people's health shall be prohibited.
　@@　Article 27. For any medicine which is to be imported for the first
time,　the　 importer　 must　submit　the　manuals,　quality　standards,
methods　 of inspection　and　other　related　information　and　samples,
as　 well　as　the　exporting　　country's　　(region's)　 certification
documents　　approving　　its　 production,　　to　 the　 administrative
department　 of　 health　under the State Council,　and import contracts
may be signed only with the prior approval of the said department.

@@　 Article　 28.　 Imported　medicines　must　be　inspected　by　the
pharmaceutical　　inspection　　 institutions　　authorized　　by　　the
administrative　 department of public　health　under　the State Council;
those having passed the inspection shall be allowed to be imported.
　Medicines　 to　 be　 imported in small quantities for urgent clinical
needs　by　medical　 units　 or　 for　 personal　 use　shall be handled
according to customs regulations.
　@@　Article　29.　The　administrative　department　of health under the
State　Council　shall　have　the　power　to　restrict　or　prohibit　the
export　of　traditional　 Chinese　 medicinal　 materials　and　prepared
Chinese medicines which are in short supply in the domestic market.
　@@　 Article　　30.　　Import　 Licences　or　Export　Licences　issued
by　 the administrative　department　of　health　under the State Council
are　required　for　the　import　or export of narcotics and psychotropic
substances　falling　within　 the　 restricted　scope　prescribed by the
administrative department of health under the State Council.
　@@　 Article　 31.　 Newly　 discovered　domestic　medicinal plants or
medicinal　plants　 introduced　from　abroad　may　be　sold　only　after
they　 have　been　examined　 and　 approved　 by　 the　 administrative
department　of　health　of　the relevant　province,　autonomous　region,
or municipality directly under the Central Government.
　 @@　 Article　 32.　 Measures　for　controlling　medicinal　materials
traditionally　used　 by　local　people　in　certain　regions　shall　be
formulated　 by　the administrative department of health under the State
Council.
　@@　 Article　 33.　The　production　and　sale　of　fake medicines are
prohibited. A fake medicine has either of the following characteristics:
　(1)　 The　names of its components are different from those prescribed
for　 it　 by　 state　 pharmaceutical　 standards　 or　 pharmaceutical
standards　　of　　the　relevant　 province,　 autonomous　 region,　 or
municipality directly under the Central Government;
　(2)　 A　non-medical　substance　is　passed　off as a medicine, or one
medicine is passed off as another.
　A　medicine　shall be handled as fake medicine in any of the following
cases:
　(1)　 Where　the　use　of　the　medicine　has　been　prohibited by the
administrative department of health under the State Council;
　(2)　 Where　 the　 medicine　 produced　 without　 being　 assigned a
registration
number;
(3) Where the medicine has deteriorated and cannot be used as such; or
　(4)　Where　the　medicine　has been contaminated and cannot be used as
such.
　@@　 Article　 34.　The　production　and sale of medicines of inferior
quality　shall　be　prohibited.　A　medicine　of　inferior　quality　has
any　of the following characteristics:
　(1)　 The　 components　of　the　medicine does not conform in quantity
to　that required　by　state　pharmaceutical standards or pharmaceutical
standards　 of　 the　　relevant　　province,　 autonomous　 region,　or
municipality directly under the Central Government;
(2) The medicine has passed its expire date; or
　(3)　The　medicine　fails　to　meet　the prescribed standards in other
respects.
　@@　 Article　　35.　　Personnel　 in　 pharmaceutical　 producing　or
trading　enterprises　 and　 in　 medical units, who have direct contact
with　 medicines,　must　 undergo　 an　 annual　 medical　 examination.
Persons　who　have　contracted　contagious　　diseases　 or　 any　other
disease　　which　 may　 contaminate　 the　medicines　 shall　 not　 be
allowed　 to　 engage　 in　any　work　which　has　direct　contact　with
pharmaceuticals.

CHAPTER VI ADMINISTRATION OF PHARMACEUTICALS AT MEDICAL UNITS
　 @@　　Article　 36.　 Packaging　 must　 meet　the　specific　quality
requirements　of the　 pharmaceuticals　and　facilitate　their　storage,
transportation　 and　medical　 use.　 If　 a　medicine　has a period of
validity, it must be clearly indicated on the package.
　Traditional　　Chinese　　medicinal　 materials　 must　 be　 packaged
before　transportation.　 There　 must appear on the package the name of
the　medicine, place　of production, date, name of the consignor, and an
indication showing that the quality of the medicine is up to standard.
　@@　 Article　 37.　 Packages　of　pharmaceuticals must, in accordance
with the regulations, be labeled and include directions for use.
　The　　label　　or　　directions　 must　 indicate　the　name　of　the
medicine,　specifications,　the　producer,　registration　number,　batch
number　 of　 the　 product,　　principal　　components,　　indications,
directions　 for　 use　dosage, contraindications, adverse reactions and
precautions.
　Special　 indications　must　be　printed　as required on the labels of
narcotics,　psychotropic　 substances,　 toxic　drugs, radioactive drugs
and medicines for external use.
　@@　 Article　　38.　 A　pharmaceuticals　trading　enterprise　engaged
in　 the repackaging　of medicines must possess the necessary facilities
and　sanitary　conditions　 suitable for the purpose, and pharmaceutical
technicians　must　be　placed　 in　charge of this work. The repackaging
records must be complete and
accurate.
　The　 repackaged　medicine must enclose directions for use, and on the
package　must　 be　 indicated the name of the medicine, specifications,
the　producter,　the　 batch number of the product, the repackaging unit
and　the　lot number of the　repackaged　product.　If the medicine has a
period of validity, it must also be indicated on the new package.

CHAPTER VII PHARMACEUTICALS UNDER SPECIAL CONTROL
　@@　 Article　 39.　 The　 state　 adopts　special　measures　for　the
control　of　narcotics,　 psychotropic　 substances,　 toxic　drugs　and
radioactive　drugs. Regulations　for the control of these drugs shall be
formulated by the State Council.
　@@　 Article　 40.　Narcotics,　including　their　mother　plants, must
only　be　produced　by　units　jointly　designated by the administrative
department　of　health　 under　the　State Council and other departments
concerned,　and　must be supplied　by　units　jointly　designated by the
administrative　department of health　of　provinces, autonomous regions,
and　municipalities　directly　under　the　Central　Government and other
departments concerned.

CHAPTER VIII ADMINISTRATION OF TRADEMARKS AND ADVERTISEMENTS OF PHARMACEUTICALS
　 @@　 Article　 41.　 Registered　trademarks　must　be　used　for　all
pharmaceuticals　 with　　the　　exception　　of　 traditional　 Chinese
medicinal　materials　and　their　preparations　in　ready-to-use　forms.
The　 sale　of pharmaceuticals without completing trademark registration
shall be prohibited.
　The　 registered　trademark　must　appear on the package and the label
of the medicine.
　@@　 Article　 42.　 Advertisements　 of　 pharmaceuticals　 must　 be
examined　and　approved　by　the　administrative　department　of　health
of　 the　 relevant　province,　 autonomous　 region,　 or　municipality
directly　under　the　Central　Government.　 In　 the　absence　of　such
approval,　 advertisement　 of　 any　medicine　may　not　be　published,
broadcasted, handed out or posted on walls.
　@@　 Article　　 43.　　 Foreign　　enterprises　　which　　apply　 to
advertise　pharmaceuticals　 in　China must submit relevant documents of
approval　by　the　country　 (region)　 in which the pharmaceuticals are
produced, directions for use and other relevant materials.
　@@　 Article　44.　Advertisements　of　pharmaceuticals　must　be based
on　 the　 directions　 for　 use　 approved　 by　 the　 administrative
department　 of　 health　 under　　the　　State　　Council　　or　　the
administrative　departments of health of provinces,　autonomous regions,
or municipalities directly under the Central Government.

CHAPTER IX SUPERVISION OVER PHARMACEUTICALS
　@@　 Article　 45.　 The　 administrative departments of health at and
above　 the　 county　 level　 shall　exercise　supervisory　power　over
pharmaceuticals.
　The　 administrative　 departments　of　health at and above the county
level　may set　up　organs for the administration of pharmaceuticals and
organs for the inspection of pharmaceuticals.
　@@　 Article　　46.　　There　 shall　 be　 pharmaceutical　inspectors
in　 the　administrative　 departments　 of　health　at　and　above　the
county　 level.　Pharmaceutical　 inspectors　shall　be　appointed　from
among　pharmacological　technical　personnel　and issued certificates by
the people's governments at the same level.
　@@　 Article　 47.　 Pharmaceutical　 inspectors　 are　authorized　to
exercise,　 in　 accordance　　with　　the　 regulations,　 supervision,
inspection　and　sampling　as regards　the　quality　of　pharmaceuticals
in　 the　 producing　 enterprises,　trading　 enterprises　and　medical
units　within their jurisdiction, and when necessary　may　pick　samples
at　　random　 and　 ask　 for　 relevant　 data　 in　accordance　 with
regulations.　 The　enterprises and units concerned may not refuse　such
requests　 or　withhold　relevant　data.　Pharmaceutical　inspectors are
duty　 bound　to keep confidential the technical information provided by
pharmaceutical　　producing　　enterprises　 and　 scientific　 research
institutions.
　 @@　　Article　　 48.　　 Pharmaceutical　　 producing　 enterprises,
pharmaceutical　trading　 enterprises　 and　medical　institutions shall
conduct　regular　surveys on　 the　 quality,　 curative　 effects　 and
adverse　 reactions　 of　the pharmaceuticals they have produced, traded
in or used.
　 When　　drug　 poisoning　 is　discovered,　the　medical　institution
concerned　must　promptly　report the matter to the local administrative
department of health.
　 @@　 Article　 49.　 The　 organs　 or　 personnel　 in　 charge　 of
pharmaceutical　inspection　　in　pharmaceutical　producing　enterprises
and　 pharmaceutical　trading　 enterprises　shall　receive　operational
guidance　from　the local pharmaceutical inspection organs.

CHAPTER X LEGAL RESPONSIBILITY
　@@　 Article　 50.　 Whoever　produces　or　sells fake medicines shall
have　his　fake　 medicines　and　unlawful　income　confiscated　and may
concurrently　be　fined;　 in　addition,　he　may　be ordered to suspend
production　or　business　operations　 pending　rectification,　or　have
his　　Pharmaceutical　　Producer　 Licence,　　Pharmaceutical　 Trading
Enterprise　Licence　or Dispensing Permit revoked.
　An　 individual　 who　produces or sells fake medicines, or the person
directly　responsible　 for　 a　 unit　 which commits this offence, and
thereby　endangers　people's　health, shall be investigated for criminal
liability under Article 164 of the Criminal Law.
　@@　 Article　 51.　Whoever　produces　or　sells medicines of inferior
quality　shall　　have　　his　　medicines　 of　 inferior　quality　and
unlawful　 income　confiscated　 and　may　be　fined　as　well.　If　the
circumstances　are　serious,　the　unit　 concerned　 shall　be　ordered
to　　 suspend　　 production　　 or　　business　 operations　　pending
rectification,　　or　　have　 its　 Pharmaceutical　 Producer　Licence,
Pharmaceutical Trading Enterprise Licence　or Dispensing Permit revoked.
　An　 individual　who　produces　or sells medicines of inferior quality
or　the　person　directly　responsible　for　a　unit　which commits this
offence,　and　thereby　 endangers　people's　health　and causes serious
consequences,　shall　be　investigated　 for　 criminal　 liability　 in
reference　to　the provisions of Article 164 of the Criminal Law.
　@@　 Article　 52.　 Any　unit　engaged　in the production, trading or
preparation　of　　medicines　　without　 obtaining　the　Pharmaceutical
Producer　 Licence,　Pharmaceutical　 Trading　 Enterprise　 Licence　or
Dispensing　Permit　shall　be ordered　to　suspend　production, business
operations　 or　preparation　of　such　medicines.　 The　medicines　and
unlawful income shall all be confiscated and a fine may also be imposed.
　@@　 Article　53.　Whoever　violates　any　other provision of this Law
on　　the　　administration　　of　　pharmaceutical　　production　　and
pharmaceutical　trading shall be served a warning or be fined.
　@@　 Article　　54.　　The　　decision　 to　mete　out　administrative
sanctions　stipulated　in　this　Law shall be made by the administrative
departments　of　health　　at　　or　　above　　the　county　level.　The
decision　 to　 mete　 out　administrative　sanctions　for violations of
the　provisions　of　Article 15 or of　CHAPTER　Eight　on administration
of　advertisements　of　this　Law　shall　be　made by the administrative
departments for industry and commerce.
　Punishment　 by　 suspension　of　production　or　business　operations
pending　rectification　 for　 seven　days or more, or revocation of the
Pharmaceutical　Producer　Licence　or　Pharmaceutical Trading Enterprise
Licence　to be meted out　to　pharmaceutical　producing　enterprises　or
pharmaceutical　 trading enterprises　directly under the jurisdiction of
the　 Central　Government　or　of　the　　 people's　　governments　　of
provinces,　　autonomous　　regions,　 or municipalities　directly under
the　Central　Government,　shall　be　submitted　by the　 administrative
department　　 of　 health　 of　 the　 relevant　 province,　autonomous
region,　or　municipality　directly　under the Central Government to the
people's　government at the same level for final decision. Punishment by
suspension　 of　 production　or　business　operations for seven days or
more,　 or　 revocation　 of　the　Pharmaceutical　Producer　Licence　or
Pharmaceutical　 Trading　 Enterprise　 Licence,　to　be　meted　out　to
pharmaceutical　 producing　 enterprises　 or　 pharmaceutical　 trading
enterprises　 under　the　jurisdiction　of　people's　governments　at or
below　 the　 city　 or　 county　 level,　shall　be　submitted　by　the
administrative　 department　of health of the people's governments at or
below　the　 city　 or　county　level to the people's governments at the
same level for final decision.
　The　 confiscated　 pharmaceuticals　shall　be　disposed　of under the
supervision of the administrative departments of health.
　@@　 Article　 55.　 If　 the　party　concerned　does　not　accept the
administrative　sanction　 decided　 on,　 it　 may　 file a suit in the
people's　court　within　15　days　 after　receiving notification of the
sanction.　However,　the　said　party　must　immediately　carry　out the
decision　on　the　control　of　pharmaceuticals made　by　administrative
department　of health. If the party neither complies with　sanction　nor
files　a　suit within the time limit, the organ which made the　decision
on　 the　administrative　sanction shall apply to the people's court for
compulsory execution.
　@@　 Article　56. If any individual or unit, in violation of this Law,
causes　drug　poisoning,　he　or　it shall be liable for the damage. The
victims　may request　the　administrative　department　of　health　at or
above　the　county　level　to　handle　the　matter; the party which does
not　accept　the　decision　may　 file a suit in the people's court. The
victims, too, may directly bring the case to the people's court.
　The　claim for compensation must be made within a year from the day on
which　the　 victim　 or his representative is aware or should have been
aware　 of　the　damage　 done.　No　claim　for　compensation　shall　be
entertained beyond the time limit.

CHAPTER XI SUPPLEMENTARY PROVISIONS
　@@　 Article　57.　For　the　purpose　of　this　Law,　the　definitions
of the following terms are:
　"　 Pharmaceuticals　 "　 means　 articles　 intended　 for use in the
prevention,　 treatment　　or　　diagnosis　 of　 human　 diseases,　 or
intended　　to　　effect　 the　 purposive　　 regulation　　of　　human
physiological　　functions,　for　which indications,　usage　and　dosage
are　prescribed, including raw traditional Chinese　medicinal materials,
traditional　 medicines　prepared　in　ready-to-use　forms　 and　 other
prepared　Chinese medicines, medicinal chemicals and their preparations,
antibiotics, biochemical medicines, radioactive drugs, serums, vaccines,
blood products, diagnostic aids, etc.
　"　 New　 medicines　"　means　medicines　which have not been produced
in this country before.
　"　 Supplementary　materials " means the excipients and additives used
for the production and dispensing of pharmaceuticals.
　 "　　Pharmaceutical　 producing　enterprise　"　means　an　enterprise
exclusively or partly engaged in the production of pharmaceuticals.
　 "　　Pharmaceutical　 trading　 enterprise　 "　means　an　enterprise
exclusively or partly engaged in the trading of pharmaceuticals.
　@@　 Article　 58.　 The　production of pharmaceuticals referred to in
this　Law　does　not include the cultivation, collection and breeding of
all　categories　of　medicinal　materials　used　in　traditional Chinese
medicine.
　@@　Article　59.　The　administrative　department　of health under the
State　 Council　　 shall,　　pursuant　　to　　this　　Law,　 draw　 up
measures　 for　 its　implementation,　 which　 shall　 enter into force
after being submitted to and approved by the State Council.
　Measures　 for　the control of pharmaceuticals specially needed by the
Chinese　People's　 Army　shall　be formulated by the competent military
department of the state.
@@　Article 60. This Law shall enter into force as of July 1, 1985.